Extract to table

The MCTA and all associated agreements must be executed and all conditions precedent satisfied in sufficient time to permit site activation and initiation activities in advance of the FPI target date

The relevant policy information is as follows: • Policy Number: BM-CTL-2023-04182 • Policy Period: April 1, 2023 through March 31, 2024 (renewable annually) • Per-Occurrence Limit: $25,000,000 • Aggregate Limit: $75,000,000 • Subject-Injury Sublimit: $10,000,000 per occurrence / $50,000,000 aggregate The MCTA will contain insurance requirements that must be satisfied by Penterra as Sponsor

The treatment of medically necessary deviations is frequently a contentious issue in clinical trial agreement negotiations, as sponsors typically resist indemnifying sites for the consequences of deviations that were not prospectively approved by the sponsor, while sites argue that investigators must retain clinical judgment to deviate from the protocol when subject safety requires it

The MCTA must address compliance with a number of federal and state regulatory frameworks, including but not limited to: • The Federal Anti-Kickback Statute (42 U

As noted above, all payments to investigators and sites under the MCTA must be established at fair market value to mitigate risk under the Anti-Kickback Statute

The safety reporting provisions must be consistent with 21 C